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New drug aimed at easing diabetic nerve pain hits roadblock

NCT ID NCT05838755

Symptom relief Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called GSK3858279 in 147 adults with chronic nerve pain from diabetes. The goal was to see if it could reduce pain better than a placebo. However, the trial was terminated early, so we have less information than planned.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GSK3858279
What this could lead to
If successful, this could point toward a new option for managing chronic nerve pain in people with diabetes.
What could go wrong
The trial was terminated early, so results are limited. It is still in early testing (Phase 2), and many drugs fail to show benefit at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

147 people

The number who actually took part.

Started

Sep 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must be 18-75 years of age inclusive, at the time of signing the informed consent. * Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration. * A pain score ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10) for average daily pain intensity over the past 24 hours at the screening visit. * Body mass index (BMI) within the range 18-40 kilogram per meter square (kg/m\^2) (inclusive) * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments. * Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia). * History of significant allergies to monoclonal antibodies. * Current enrolment or past participation in a clinical study of an investigational medicinal product intervention within the last 30 days or 5 half-lives (whichever is longer) of signing consent. * Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits, inability to complete the eDiary daily etc.) and/or otherwise considered by the Investigator to be unlikely to complete the study.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic neuropathy neuralgia Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain

Contacts and locations

Locations

  • GSK Investigational Site

    Anniston, Alabama, 36207, United States

  • GSK Investigational Site

    Surprise, Arizona, 85378, United States

  • GSK Investigational Site

    Cerritos, California, 90703, United States

  • GSK Investigational Site

    Lomita, California, 90717, United States

  • GSK Investigational Site

    Largo, Florida, 33777, United States

  • GSK Investigational Site

    Miami, Florida, 33135, United States

  • GSK Investigational Site

    Miami, Florida, 33175, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33401, United States

  • GSK Investigational Site

    Decatur, Georgia, 30030, United States

  • GSK Investigational Site

    Chicago, Illinois, 60611, United States

  • GSK Investigational Site

    Waltham, Massachusetts, 02451, United States

  • GSK Investigational Site

    Williamsville, New York, 14221, United States

  • GSK Investigational Site

    Huntersville, North Carolina, 28078, United States

  • GSK Investigational Site

    Lancaster, South Carolina, 29720, United States

  • GSK Investigational Site

    Cypress, Texas, 77429, United States

  • GSK Investigational Site

    DeSoto, Texas, 75154, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    McAllen, Texas, 78501, United States

  • GSK Investigational Site

    Bellevue, Washington, 98007, United States

  • GSK Investigational Site

    New Westminster, British Columbia, V3L 3W4, Canada

  • GSK Investigational Site

    Vancouver, British Columbia, V5Y 3W2, Canada

  • GSK Investigational Site

    Winnipeg, Manitoba, R3C 0N2, Canada

  • GSK Investigational Site

    Toronto, Ontario, L6S 0C6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4, Canada

  • GSK Investigational Site

    Beijing, 100032, China

  • GSK Investigational Site

    Guangzhou, 510000, China

  • GSK Investigational Site

    Harbin, 150001, China

  • GSK Investigational Site

    Luoyang, 471003, China

  • GSK Investigational Site

    Shanghai, 200032, China

  • GSK Investigational Site

    Wuhan, 430030, China

  • GSK Investigational Site

    Yueyang, 414000, China

  • GSK Investigational Site

    Corbeil-Essonnes, 91100, France

  • GSK Investigational Site

    Mulhouse, 68100, France

  • GSK Investigational Site

    Bad Homburg, 61348, Germany

  • GSK Investigational Site

    Mainz, 55128, Germany

  • GSK Investigational Site

    Münster, 48145, Germany

  • GSK Investigational Site

    Wallerfing, 94574, Germany

  • GSK Investigational Site

    Chiba, 260-0804, Japan

  • GSK Investigational Site

    Fukuoka, 807-8556, Japan

  • GSK Investigational Site

    Gunma, 370-3573, Japan

  • GSK Investigational Site

    Hokkaido, 060-0061, Japan

  • GSK Investigational Site

    Ibaraki, 300-0028, Japan

  • GSK Investigational Site

    Kanagawa, 211-8533, Japan

  • GSK Investigational Site

    Osaka, 565-0853, Japan

  • GSK Investigational Site

    Tochigi, 321-0204, Japan

  • GSK Investigational Site

    Tochigi, 321-0974, Japan

  • GSK Investigational Site

    Tochigi, 322-8550, Japan

  • GSK Investigational Site

    Tokyo, 103-0027, Japan

  • GSK Investigational Site

    Tokyo, 104-0031, Japan

  • GSK Investigational Site

    Tokyo, 143-0015, Japan

  • GSK Investigational Site

    Tokyo, 160-0008, Japan

  • GSK Investigational Site

    Częstochowa, 42-217, Poland

  • GSK Investigational Site

    Gdynia, 81-338, Poland

  • GSK Investigational Site

    Katowice, 40-081, Poland

  • GSK Investigational Site

    Katowice, 40-282, Poland

  • GSK Investigational Site

    Katowice, 40-648, Poland

  • GSK Investigational Site

    Katowice, 40-749, Poland

  • GSK Investigational Site

    Skorzewo, 60-185, Poland

  • GSK Investigational Site

    Sochaczew, 96-500, Poland

  • GSK Investigational Site

    Warsaw, 02-117, Poland

  • GSK Investigational Site

    Cape Town, 7530, South Africa

  • GSK Investigational Site

    Johannesburg, 2196, South Africa

  • GSK Investigational Site

    KwaDukuza, 4450, South Africa

  • GSK Investigational Site

    Pretoria, 0184, South Africa

  • GSK Investigational Site

    Somerset West, 7130, South Africa

  • GSK Investigational Site

    Bucheon-si, 422711, South Korea

  • GSK Investigational Site

    Daejeon, 35233, South Korea

  • GSK Investigational Site

    Seoul, 120-752, South Korea

  • GSK Investigational Site

    Seoul, 136-705, South Korea

  • GSK Investigational Site

    Seoul, 137-701, South Korea

  • GSK Investigational Site

    Seoul, South Korea

  • GSK Investigational Site

    A Coruña, 15006, Spain

  • GSK Investigational Site

    Barcelona, 08023, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    Palma de Mallorca, 07120, Spain

  • GSK Investigational Site

    San SebastiAn de Los Rey, 28702, Spain

  • GSK Investigational Site

    Torrevieja Alicante, 3186, Spain

  • GSK Investigational Site

    Cannock, WS11 0BN, United Kingdom

  • GSK Investigational Site

    Liverpool, L9 7AL, United Kingdom

  • GSK Investigational Site

    Teesside, TS17 6EW, United Kingdom

  • GSK Investigational Site

    West Yorkshire, LS10 1DU, United Kingdom

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